Klassic ONE Universal Cone & Revision Baseplate Tray, Baseplate Insert

GUDID 00810094692544

Cone & Revision Baseplate Instrumentation Tray, Baseplate Insert

TOTAL JOINT ORTHOPEDICS, INC.

Instrument tray, reusable
Primary Device ID00810094692544
NIH Device Record Keyeb7c1f74-1451-416e-927e-c9171dbfe023
Commercial Distribution StatusIn Commercial Distribution
Brand NameKlassic ONE Universal Cone & Revision Baseplate Tray, Baseplate Insert
Version Model Number2417.00.200
Company DUNS078416717
Company NameTOTAL JOINT ORTHOPEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8014866070
Emailbsiddoway@tjoinc.com
Phone8014866070
Emailbsiddoway@tjoinc.com
Phone8014866070
Emailbsiddoway@tjoinc.com
Phone8014866070
Emailbsiddoway@tjoinc.com
Phone8014866070
Emailbsiddoway@tjoinc.com
Phone8014866070
Emailbsiddoway@tjoinc.com
Phone8014866070
Emailbsiddoway@tjoinc.com
Phone8014866070
Emailbsiddoway@tjoinc.com
Phone8014866070
Emailbsiddoway@tjoinc.com
Phone8014866070
Emailbsiddoway@tjoinc.com
Phone8014866070
Emailbsiddoway@tjoinc.com
Phone8014866070
Emailbsiddoway@tjoinc.com
Phone8014866070
Emailbsiddoway@tjoinc.com
Phone8014866070
Emailbsiddoway@tjoinc.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic Knee System should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100810094692544 [Primary]

FDA Product Code

OJHOrthopedic Tray

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810094692544]

Moist Heat or Steam Sterilization


[00810094692544]

Moist Heat or Steam Sterilization


[00810094692544]

Moist Heat or Steam Sterilization


[00810094692544]

Moist Heat or Steam Sterilization


[00810094692544]

Moist Heat or Steam Sterilization


[00810094692544]

Moist Heat or Steam Sterilization


[00810094692544]

Moist Heat or Steam Sterilization


[00810094692544]

Moist Heat or Steam Sterilization


[00810094692544]

Moist Heat or Steam Sterilization


[00810094692544]

Moist Heat or Steam Sterilization


[00810094692544]

Moist Heat or Steam Sterilization


[00810094692544]

Moist Heat or Steam Sterilization


[00810094692544]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-05
Device Publish Date2025-07-28

Devices Manufactured by TOTAL JOINT ORTHOPEDICS, INC.

00810094692544 - Klassic ONE Universal Cone & Revision Baseplate Tray, Baseplate Insert2025-08-05Cone & Revision Baseplate Instrumentation Tray, Baseplate Insert
00810094692544 - Klassic ONE Universal Cone & Revision Baseplate Tray, Baseplate Insert2025-08-05 Cone & Revision Baseplate Instrumentation Tray, Baseplate Insert
00810094692339 - Acetabular Reamer Adapter2025-07-04
00810094691790 - Klassic Knee Templates, Stem Extensions2025-05-22 Knee Templates, Stem Extensions
00810094692322 - Spline Wrench, Closed2025-05-22
00810094692346 - Intramedullary Reamer, Revision2025-05-22 Intramedullary Reamer, Revision, Sz 10
00810094692353 - Intramedullary Reamer, Revision2025-05-22 Intramedullary Reamer, Revision, Sz 11
00810094692360 - Intramedullary Reamer, Revision2025-05-22 Intramedullary Reamer, Revision, Sz 12
00810094692377 - Intramedullary Reamer, Revision2025-05-22 Intramedullary Reamer, Revision, Sz 13

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.